Michał Górka

Head of ADMET and Bioanalysis Research Group at Celon Pharma S.A.
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Contact Information
us****@****om
(386) 825-5501
Location
Poland, PL
Languages
  • Polish Native or bilingual proficiency
  • English Full professional proficiency
  • German Elementary proficiency

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Experience

    • Poland
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Head of ADMET and Bioanalysis Research Group
      • Mar 2020 - Present

      Responsible for the provision of practical and strategic bioanalytical mass spectrometry with major focus on large molecules:- physicochemical analysis of proteins- proteome profiling- protein biomarker discovery- bioanalysis and targeted analysisResponsible for development and coordination of state-of-the-art biophysical and structure-based methods:- analysis of potential protein-protein and protein-small molecule interactions- characterization of potential interactions of protein with cells- determination of protein structures- development of high-throughput screening testsResponsible for quality control and release of manufactured proteins obtained under GMP system:- preparation and implementation of analytical methods- transfer of analytical methods- protein production control - IPCResponsible for the planning, designing, data analysis, interpretation, reporting, presentation and discussion of studies for in vitro characterization of ADME properties of drug candidates:- metabolic stability of compounds- permeability of drug candidates- metabolite identification and profiling- drug distribution- toxicity of compounds- PK research interpretation- drug-drug interaction studiesThe role included laboratory management responsibilities of couple scientists, LC/MS instrumentation and mentorship/coaching of more junior staff. A major remit of this role was to re-design new assays and methodologies, including in vitro metabolism, bioanalysis, cell-based assays and metabolite identification to make them more compatible with the needs of the research function and to introduce new assays to facilitate the progress of lead optimization projects.

    • Senior Analyst & Mass Spectrometry Specialist
      • Mar 2019 - Mar 2020

      Using state-of-the-art chromatographic and mass spectrometric instrumentation and methods, I apply my expertise built up over couple of years of pioneering academic and industrial research including Proteomics, Metabolomics and Small Molecules. Specialising in structural characterisation and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies (mAb) and associated products particularly in the discovery, early Phase and pre-clinical phases.Applying high resolution LC-MS instrumentation and software to the structural and physicochemical characterization of biopharmaceuticals and ensure effective operation and proper maintenance of instruments at the Celon Pharma facility. Carry out characterization studies to assess key attributes of biopharmaceuticals such as:- amino acid sequence (mapping and de novo)- intact molecular weight- disulfide bridge configuration - post-translational modifications- glycosylation- host cell proteins- detection of impurities in drug samples - determination of aggregation levelResponsibilities also include validation of analitycal methods, preparation of reports and development of SOPs.𝐌𝐚𝐬𝐬 𝐒𝐩𝐞𝐜𝐭𝐫𝐨𝐦𝐞𝐭𝐫𝐲 𝐚𝐧𝐝 𝐇𝐏𝐋𝐂 𝐢𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭 𝐬𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐬𝐭:o TripleTOF® 6600 System (AB Sciex)o M3 MicroLC-TE (AB Sciex)o Dionex Ultimate 3000 (Thermo Scientific)o Vanquish Horizon (Thermo Scientific)

    • Biotechnology Research
    • 100 - 200 Employee
    • Proteomic specialist & Post-Doctoral Researcher
      • Dec 2017 - Feb 2019

      - Instrumentation Specialist for Mass Spectrometry equipmento Q Exactive Plus o Q Exactive HFo Q Exactive Focuso LTQ Veloso LTQ Orbitrap XLo EASY-nLC HPLC (Thermo Scientific)o ACQUITY UPLC (Waters)- Independent troubleshooting and maintenance of HPLC/UPLC and mass spectrometry platforms- Protein and metabolite annotation and quantification specialist- Development of qualitative/quantitative mass spectrometry assays with a strong analytical background- Highly experienced with designing and execution of proteomics/metabolomics experiments including label and label-free quantification approaches - Protein-protein and protein-metabolite interaction assays including computational approaches to compare protein elution profiles

    • Doctoral Researcher
      • Feb 2014 - Nov 2017

      - Independent user of Thermo Scientific HPLC and mass spectrometry platforms- Independent troubleshooting and maintenance of HPLC and mass spectrometry platforms- Protein-protein interaction assays - Protein separation techniques (size exclusion chromatography, ultracentrifugation, electrophoresis)- Protein expression and purification in bacterial system- Molecular and Microbiological techniques (PCR, gateway cloning, plasmid transformation)

    • Biotechnology Research
    • 100 - 200 Employee
    • Internship
      • Feb 2013 - Dec 2013

      Student worker in Signaling Proteomic Group:- Operation of Orbitrap-type mass spectrometer and analysis of proteomic data- Maintaining plant cell cultures and performing specific drug treatments- Isolation and identification of membrane rafts located proteins (Western Blot) Student worker in Signaling Proteomic Group:- Operation of Orbitrap-type mass spectrometer and analysis of proteomic data- Maintaining plant cell cultures and performing specific drug treatments- Isolation and identification of membrane rafts located proteins (Western Blot)

    • Lab Assistant
      • Aug 2012 - Sep 2012

      - Preparation of samples and reagents for testing- Carrying out analysis of blood samples - Preparation of samples and reagents for testing- Carrying out analysis of blood samples

    • Internship
      • Jul 2012 - Jul 2012

      - In situ hybridization (ISH) to identify HPV oncogenic viruses- Microscope diagnostic of immunohistochemical specimens - In situ hybridization (ISH) to identify HPV oncogenic viruses- Microscope diagnostic of immunohistochemical specimens

    • Student Volunteer
      • Jan 2010 - Jul 2010

      - Maintaining bacterial cultures- Isolation of DNA and RNA- Protein and nucleic acids electrophoresis - Maintaining bacterial cultures- Isolation of DNA and RNA- Protein and nucleic acids electrophoresis

Education

  • Max Planck Institute for Molecular Plant Physiology
    PhD
    -
  • University of Wroclaw
    Master's degree, Biotechnology
    2011 - 2014
  • University of Wroclaw
    Bachelor's degree, Biotechnology
    2008 - 2011

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